锦鲤求职岗位描述
工作职责JOB RESPONSIBILITY
1. 负责仓库管理部审计对接，可应对境外客户、官方等现场审计沟通及国内药监核查，完成英文资料筹备、现场答疑、沟通对接。 Be responsible for the audit connection of warehouse, and complete the preparation of English materials, on-site answering questions and communication connection for on-site audit communication of overseas customers and authorities as well as domestic drug regulatory inspection.
2. 全面配合内外部 GMP 审计、官方检查工作，对接审计问询、提交相关资料，按要求完成问题整改与闭环。
Fully support internal and external GMP audits and official inspections, respond to inquiries, submit relevant documents, and complete rectification and closure of non-conformities in a timely manner.
3. 日常仓库管理过程中内外部客户的项目对接沟通 Project docking communication between internal and external customers during daily warehouse management
4. 仓库相关SOP流程搭建、修订与持续优化，排查业务漏洞与合规风险，负责仓储模块日常培训、作业指导及技能培训，规范现场标准化作业。 Lead SOP construction, revision and continuous optimization of WH, investigate business loopholes and compliance risks, be responsible for daily training, operation guidance and skill training of storage module, and standardize on-site standardization.
5. 具备较强逻辑思维与文字撰写能力，独立完成中英文审计整改报告、偏差、CAPA、风险评估、制度文件等各类合规材料编撰，跟进审计问题闭环落地。 Having strong logical thinking and writing ability, independently completing the compilation of various compliance materials such as audit rectification reports, deviations, CAPA, risk assessment, and institutional documents in Chinese and English, and following up the closed loop landing of audit problems.
6. 严格遵守公司安全及合规管理制度，坚守安全作业准则。
Strictly abide by the company's safety and compliance regulations and adhere to safety guidelines.
7. 支持跨基地、跨团队仓库业务相关工作。
Support cross-base and cross-team warehouse business-related work..
8. 完成上级交办的其他临时性工作任务。
Complete other temporary work assigned by superiors.
最低任职要求Minimum Requirement
1. 行业经验：3年以上生物医药行业仓储管理经验
Experience: 3+ years in biopharmaceutical warehouse management
2. 法规掌握：熟悉GMP/GDP规范及数据完整性要求 Regulatory Expertise: Proficient in GMP/GDP regulations and data integrity requirements
3. 语言技能：可应对全英文客户审计，熟练编制英文合规文件
Language Proficiency: Able to conduct full-English client audits and prepare compliance documentation
4. 审计能力：具有NMPA/FDA/EMA等国际GMP审计迎检及整改经验
Audit Capability: Experience in hosting NMPA/FDA/EMA GMP audits and implementing corrective actions
5. 体系管理：能够独立完成SOP编制、变更控制、偏差处理及CAPA闭环管理
System Management: Skilled in SOP development, change control, deviation resolution and CAPA closure
6. 核心能力：具备优秀的项目推进、跨部门协调及制度文档撰写能力
Core Competencies: Strong project execution, cross-functional coordination and policy documentation skills
7. 逻辑思维严谨，问题排查与整改推进能力强，具备高度合规意识。细致负责，抗压能力强，恪守药品质量管理规范
Professional Attributes: Analytical problem-solving ability with strict compliance awareness. Detail-oriented, responsible, resilient to pressure, committed to quality standards
8. 学历背景：药学、制药工程、生物工程或物流管理相关专业本科及以上学历
Education: Bachelor degree or above in Pharmacy, Pharmaceutical Engineering, Biotechnology or Logistics Management
9. 其他要求：能够根据工作安排配合加班，适应岗位工作需求。
Other Requirements: Able to work overtime as required by job arrangements.